The ideal candidate will gather requirements, create test plans, test cases, define and implement test strategies, and test medical device software, in accordance with industry standards and regulations.
- Establish test methodologies and acceptance criteria, execution of test protocols, data analysis, investigation, and writing final reports
- Analyze system requirements and develop test plans, cases and excute on these requirements
- Partner with engineering team to document and refine requirements
- Good technical writing skills, including development of test methods, protocols, reports.
- Facilitate documentation and tracking of verification activities
- Assess and evaluate new tools and testing methodologies
- Generate defect reports in defect tracking system and verification of correct technical fixes using such systems as Jira, ClearQuest, Helix ALM, etc.
- Perform regression analysis/testing and associated documentation on software release changes
- Demonstrate understanding of complete software development lifecycle phases
- Experience in a team oriented traditional waterfall or fast-paced agile development processes, working closely with developers during feature development and testing phases
- Develop and implement quality metrics associated with software development and performance
- Bachelor’s degree in relevant engineering discipline or equivalent experience. BS with a Computer Science concentration, preferred. MS preferred
- Minimum of three to five (3-5) years’ experience with relevant and recent experience performing the same or similar type of work as required by the position in compliance with the recognized standards below.
- Class I, II and III medical device verification and validation experience or equivalent
- Working knowledge and/or understanding of the requirements of FDA QSRs, ISO 13485, IEC 62304, IEC 60601 and ISO14971
- Experience with defect tracking and metrics
- Experience with requirements management software such as Helix ALM, Jama or Doors
- Proficient computer skills with applicable software packages (e.g. Microsoft Office, Matlab, Excel, etc.)